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Trial registered on ANZCTR


Registration number
ACTRN12612001009808
Ethics application status
Approved
Date submitted
9/01/2012
Date registered
19/09/2012
Date last updated
24/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Healthy Bowels Study - A randomised controlled trial of transcutaneous electrical stimulation to treat constipation caused by anorectal retention in children.
Scientific title
Children (aged 4-8 years) with chronic constipation caused by anorectal retention treated with current best treatment (CBT) plus transcutaneous electrical stimulation compared to CBT alone comparing laxative usage after 8 weeks of TES.
Secondary ID [1] 279688 0
none
Universal Trial Number (UTN)
U1111-1126-9593
Trial acronym
Healthy Bowels Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Constipation 285513 0
Condition category
Condition code
Oral and Gastrointestinal 285707 285707 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised Current Best Treatment (CBT) vs. CBT plus transcutaneous electrical stimulation (TES).
Open treatment, Blinded analysis.

CBT involves 4 x 3hours patient education sessions (12 hours in total) which include basic digestive function, prescriptive diet and maintenance medication. These are given over 4 weeks before the 8 weeks of TES commences.

TES involves patients having daily stimulation using the TES device (4 electrode pads over the abdomen and lower back) for one hour daily for 8 weeks.

For entry patients will be assessed for anorectal retention by A/ History and presence of palpable faecaloma B/ confirmation by radio-nuclear transit study

All subjects receive:
a disimpaction regime using over the counter stool softener and laxative (similar to bowel washout used before colonoscopy), education on how the bowel works, controlled diet and fluid intake, Maintenance medication: Stool softener and laxative for 14 weeks. Amount of laxative will be increased or decreased to maintain stool at 1 cup per day and medium consistency (measured using Bristol Stool Chart) and Patients will fill in an online diary each day.

At 4 weeks, patients will be randomised to Group A or B.

Group A (control group) continue current best treatment. Which involves a combination of detailed education and laxative medication for the duration of 8 weeks.

Group B (electrical stimulation group) continue with current best treatment (as mentioned above) plus the use of the Transcutaneous Electrical Stimulation (TES) used daily for 1 hour each day, for the duration of 8 weeks.
Intervention code [1] 283979 0
Treatment: Devices
Comparator / control treatment
All subjects receive

a/ a disimpaction regime using over the counter stool softener and laxative (similar to bowel washout used before colonoscopy),

b/ education on how the bowel works

c/ controlled diet and fluid intake

d/ Maintenance medication: Stool softener and laxative for 14 weeks. Amount of laxative will be increased or decreased to maintain stool at 1 cup per day and medium consistency (measured using Bristol Stool Chart).

e/ Patients will fill in an online diary each day.


All patients continue on maintenance medication for 3 months.

Patients continuing on CBT will be known as Group A (control group).

Patients continuing on CBT + TES will be known as Group B (treatment group)

NB: please refer to the Descriptions of Intervention(s) for further explanation on CBT and TES machine use.
Control group
Active

Outcomes
Primary outcome [1] 286234 0
Laxative: Medication dosage administered to patient to maintain bowel consistency of type 4 Bristol Stool Chart.
(as per IMPACT Paediatric Bowel Care Pathway - Australia) 2006
Timepoint [1] 286234 0
End of week 8 of CBT+TES/ CBT
Primary outcome [2] 287689 0
Percent of patients using laxatives at end of 8 weeks of CBT+TES/ CBT
Timepoint [2] 287689 0
End of week 8 of CBT+TES/ CBT
Secondary outcome [1] 295425 0
Time to ceasing laxative use
Timepoint [1] 295425 0
Daily collection of laxative use data for the full term of the study.
Secondary outcome [2] 295860 0
Number of patients ceasing laxative use
Timepoint [2] 295860 0
Daily collection of laxative use data for the full term of the study.
Secondary outcome [3] 298626 0
Defecation episodes/day
Timepoint [3] 298626 0
Daily collection of patient diary data for the full term of the study.
Secondary outcome [4] 298627 0
soiling episodes/day
Timepoint [4] 298627 0
Daily collection of patient diary data for the full term of the study.
Secondary outcome [5] 298628 0
Quality of life - PAC qol, PAC sym questionnaire
Timepoint [5] 298628 0
Before starting trial, post disimpaction (pre CBT commencing), Post 8 weeks CBT+TES/ CBT
Secondary outcome [6] 298629 0
Consistency of stool- as per Bristol Stool Chart.
Timepoint [6] 298629 0
Daily collection of patient diary data for the full term of the study.

Eligibility
Key inclusion criteria
Children (4-18yrs) with treatment-resistant Anorectal Retention constipation confirmed by Nuclear Transit Study. Patients with faecaloma will be included.

For entry patients will be assessed for anorectal retention by
a/ History and presence of palpable faecaloma
b/ Confirmation by radio-nuclear transit study (scintigraphy)
Minimum age
4 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Has a heart pacemaker, neurological defects (including slow transit constipation, epilepsy), cochlear implant or ventricular-peritoneal shunt inserted.
2. Hormonal/metabolic disorder, bowel surgery, cancer or pregnancy.
3. Previous TES therapy.
4. Unable to access the internet each day to login to the computer program for medication dose and to send copies of paper diary Charts.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be recruited at Royal Children's Hospital Melbourne, Australia. Participation in the trial will be offered to patients attending the Gastroenterology, Surgical (Urology), General Medicine, Continence and Encopresis outpatient clinics and patients referred from community GP practice.

A clinical trial announcement flyer will be provided to potential patient candidates with Trial contact details. Once recruited, the Trial co-coordinator will obtain consent.

Prior to performing any study or procedure (including screening procedures to determine eligibility), a signed consent form will be obtained from each participant and or parent/ guardian. The consent form will describe the purpose of the study, the procedures to be followed, and the risks and benefits of participation. One of the investigators will conduct the informed consent discussion and will check that the participant and/ or their parent/ guardian comprehend the information provided and answer any questions about the study. Consent will be voluntary and free from coercion.

The investigator that conducted the consent discussion will also sign the informed consent form. A copy of the consent form will be given to the participant and/or their parent/guardian and the fact that the subject has been consented to the study will be documented in the subject’s record. When all the inclusion and/or exclusion criteria have been addressed and the eligibility of the subject confirmed, the subject will be enrolled into the study.

A record will be maintained of all participants screened but not enrolled due to ineligibility. Data collected at screening (specifically, eligibility data) will be recorded on these participants.

Patients will be randomly assigned to receive CBT or CBT+TESIC. The number participants in each group will be roughly equal with a minimum of 50 completing the protocol in each group.

Treatment A and B wil be randomised. The treatment will be assigned a number and then placed in a numbered envelope and sealed. The envelopes in numerical order will be assigned to each patient after disimpaction.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was performed by our statistics unit using computer generation. Treatments were randomised in variable block sizes. Allocation was placed into sealed numbered envelopes by the statistics unit. Envelopes were supplied to the trial staff and given to patients in numerical order.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6980 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 14690 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 284469 0
Government body
Name [1] 284469 0
NHMRC
Address [1] 284469 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 284469 0
Australia
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Level 5
The Royal Children's Hospital
50 Flemington Road
Parkville, 3052
Victoria
Country
Australia
Secondary sponsor category [1] 284129 0
None
Name [1] 284129 0
N/A
Address [1] 284129 0
Country [1] 284129 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286452 0
Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 286452 0
Ethics committee country [1] 286452 0
Australia
Date submitted for ethics approval [1] 286452 0
09/01/2012
Approval date [1] 286452 0
29/06/2012
Ethics approval number [1] 286452 0
32014

Summary
Brief summary
This study will assess if a safe non-invasive transcutantous electrical stimulation can treat chronic constipation from the anorectal retention sub-group (the most common type of chronic constipation).
Hypothesis
TESIC can increase large bowel motility and defecation to overcome chronic constipation in children with AR, and is more effective than current best treatment (CBT, laxatives, diet, toilet timing and posture, education about brain-gut axis) alone.
Trial website
www.healthybowelstrial.org.au (pending - to be activated)
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33603 0
Dr Bridget Southwell
Address 33603 0
Surgical Research Group, Murdoch Childrens Research Institute, Level 5 East, The Royal Children’s Hospital, 50 Flemington Road Parkville Victoria 3052
Country 33603 0
Australia
Phone 33603 0
+61 3 9345 5069
Fax 33603 0
Email 33603 0
bridget.southwell@mcri.edu.au
Contact person for public queries
Name 16850 0
Dr Dr Bridget Southwell
Address 16850 0
Surgical Research Group, Murdoch Childrens Research Institute,
Level 5 East, The Royal Children’s Hospital,
50 Flemington Road
Parkville Victoria
3052
Country 16850 0
Australia
Phone 16850 0
61 3 9345 5069
Fax 16850 0
Email 16850 0
bridget.southwell@mcri.edu.au
Contact person for scientific queries
Name 7778 0
Dr Dr Bridget Southwell
Address 7778 0
Surgical Research Group, Murdoch Childrens Research Institute,
Level 5 East, The Royal Children’s Hospital,
50 Flemington road,
Parkville.
Victoria
3052
Country 7778 0
Australia
Phone 7778 0
61 3 9345 5069
Fax 7778 0
Email 7778 0
bridget.southwell@mcri.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary